The Legal Basis for International Research
Including Georgia in a multicentre international clinical trial is a manageable task when several interconnected norms of the Law of Georgia on Drugs and Pharmaceutical Activities are properly accounted for. Article 5¹ of the law sets the general rule for preclinical and clinical research: research is conducted in accordance with the standards and guidelines approved by the relevant Minister, and its start requires a permit. The coordination of an international trial builds its practical questions precisely around this general rule.
The rights of patients and healthy volunteers participating in the research are protected by the legislation of Georgia, and this protection does not vary with the number of countries in which the trial runs simultaneously. Involving a Georgian centre in an international protocol does not release the sponsor from local requirements — on the contrary, it is the local legal framework that determines which data will be valid and which obligations must be performed for the Georgian market.
Research Conducted Under a Foreign Regulator's Control
Article 5¹ attaches decisive importance to the market on which the research is permitted. Under the law, it is permissible in Georgia for a healthy volunteer to undergo a study that is permitted on a market subject to the control of a foreign or international state regulatory body for pharmaceutical products recognised under the legislation of Georgia, and which is conducted on healthy volunteers. This norm allows the coordinator of an international trial to link the involvement of a Georgian centre to the foreign market where the same study is running under the regulator's supervision.
The law also sets a separate condition for clinical research into a pharmacological agent intended as an advanced therapy medicinal product: such research is permissible if the agent is manufactured under a standard of good manufacturing practice recognised by the Government of Georgia, at an enterprise holding the authorisation to manufacture biological medicinal products. When planning international research, this condition must be verified in advance together with the enterprise's authorisation documents.
Sponsor Insurance and Participant Protection
Before the start of a clinical trial, the sponsor — the person, company, institution or organisation responsible for the initiation, management or funding of the research — must secure insurance of the trial's risk and liability for the duration of its conduct. The insurance provides for the reimbursement or compensation of the treatment costs of the participant or participants, to the extent that these costs were incurred in connection with their participation. In a multicentre trial this guarantee remains mandatory for the Georgian participants as well.
Exclusivity of the Research Data
The coordination of international research is directly linked to its results. Article 4¹ of the law protects the scientific and technical information about a registered pharmaceutical product: it is prohibited to use this information for decisions on the registration of the same or a similar product unless the holder of the admission right has consented to such use. It is likewise prohibited for an applicant under the national regime to rely on the trial and research data submitted by another holder without consent.
These rules operate for six years from the first admission of the pharmaceutical product to the market of an EU member state or Georgia. The period may be extended up to seven years if, within the first six years, the holder of the basic permit obtains authorisation for a new therapeutic use of the product that is regarded as having significant clinical advantage compared with existing methods of treatment. Before relying on research data, the expiry of the exclusivity period must therefore always be checked.
The Recognition Regime for Registration
After the completion of international research, one route for admitting the product to the Georgian market is the recognition regime of state registration contemplated by Article 11⁷ of the law. This regime applies to a product that has been admitted to the relevant market by a foreign or international state regulatory body for pharmaceutical products. The Government of Georgia establishes the list of such bodies, and the interested person may be any person — under the recognition regime the purpose of import is not a restricting factor.
Under the recognition regime the interested person submits homologous identification documentation — including an authorised Georgian translation of the instruction for use, particulars of the product's form, dosage and labelling sample, the period of admission, the unique authorisation number, the certificate, and the document confirming manufacture under a good manufacturing practice standard. The Agency carries out the administrative expertise of the documentation and places the product information in the official registry within seven working days. The period for which a product admitted under this regime may remain on the market is determined by the corresponding foreign market's period, but may not exceed five years.
The norms surrounding the regime also matter: the Agency may, on the basis of a recommendation received from the foreign regulator, temporarily suspend registration until the reason for suspension is eliminated, and the expiry of the registration period entails the revocation of the document confirming the right of admission to the market. At the same time, even after expiry, the sale of the product already in circulation remains permissible until its shelf life runs out. A coordinator of international research should factor in these periods from the outset.
Frequently Asked Questions
Can a study permitted on a foreign market be conducted in Georgia on healthy volunteers?
Yes. The law permits a study on a healthy volunteer if it is permitted on a market subject to the control of a foreign or international regulatory body recognised under Georgian legislation and is conducted on healthy volunteers.
For how long are the research data protected?
The exclusivity of scientific and technical information operates for six years from the first admission to the market of an EU member state or Georgia, and may extend up to seven years if the holder obtains authorisation for a new therapeutic indication with significant clinical advantage.
What is the recognition regime of state registration?
It is a simplified route for admitting a product to the Georgian market when it has already been admitted by a recognised foreign or international regulator on the relevant market. The Agency examines the homologous documentation within seven working days, and the admission period may not exceed five years.
Who arranges the insurance of an international trial?
Insurance is the sponsor's obligation: the sponsor secures risk insurance for the entire duration of the research so that participants' treatment costs are reimbursed or compensated.
How We Help on Legal.ge
International trial coordination requires simultaneously weighing Georgian legislation, the requirements of foreign regulators and the commercial objectives of the research. On Legal.ge we help with the legal assessment of involving a Georgian centre, calculating data exclusivity periods and preparing the documentation for the recognition regime. Contact us — we will analyse your situation for a concrete decision.